BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-SCR Ø2 SELF-DRILL L8 TAN

    MDR report key: 3051380 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-01568
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K974555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    A BREAKAGE OF THE TURNING TOOL HAS CAUSED THE REPORTED ISSUE. THE HEAD OF THE SCREW WAS NOT MANUFACTURED TO SPECIFICATION, PREVENTING THE STAR DRIVE FROM FUNCTIONING INTERACTIVELY WITH THE SCREW HEAD.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE SCREW HEAD OF THE LOCKING SCREW IS DEFECTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149786 LOCK-SCR Ø2 SELF-DRILL L8 TAN BONE PLATE JEY SYNTHES GMBH 8051289

    Patients

    Seq Age Sex Outcome Treatment
    1